Study design and rationale of a mock phase I trial as an educational tool for clinical pharmacology residents.

摘要

OBJECTIVE: To invite comments and suggestions from the phase I trialists, the world over, on the design and rationale provided by us for conducting a mock phase I trial for training clinical pharmacology residents. METHODS: The trial will be conducted by clinical pharmacology residents of the Post Graduate Institute of Medical Education and Research. After a thorough evaluation of Preclinical toxicity data of a pharmaceutical product provided by a dummy pharmaceutical firm, a randomized, double-blind, placebo controlled, parallel group design with dose escalation of the product will be carried out. A single dose administration will be followed by monitoring the participants for 24 h and again at one week. After obtaining results of the previous group, the next higher dose will be administered. Evaluation of the learners will be done by two independent teachers who will mark them for actual conduct of the study and writing a report of the study. Subsequently, we will try to publish the results of the mock trial and invite further comments. CONCLUSIONS: This trial designed primarily for training purposes will be instrumental in equipping the residents with the expertise for conducting phase I trials.